For example, though often led at the director level either by PV or Regulatory Affairs, US REMS teams often pull in several additional medical and commercial functions for various activities, including Medical Affairs, Epidemiology, Clinical Affairs and Marketing.

In addition, 35% of the companies collaborate with other organizations that support similar products or therapeutic areas, often around ETASUs or with respect to FDA interactions to help ensure compliance or learn about specific therapeutic area standards.

Other key insights include:

Market research performs a fairly narrow set of tasks within specific REMS plan components, working most often on Communication Plans (at 61% of the companies), Implementation Plans (56%) and Medication Guides (50%).

85% of the companies use regulatory feedback to determine the extent to which companies must go to fulfill communication-of-risk and safety specifications; while some 47% of the companies have initiated internal RMP-REMS collaboration.

Corporate managers who want to improve REMS and RMP effectiveness will find this report invaluable for learning what the latest trends are for risk mitigation programs.

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